MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ION; SYSTEM CART

Model Number	380707-33
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	05/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after completion of an ion endoluminal lung biopsy procedure, the patient developed a pneumothorax requiring a chest tube.The physician did not necessarily believe the ion system caused or contributed to the pneumothorax, but possibly the biopsy needle, as it is a part of the procedure to retrieve lung tissue and if the biopsy location is close to the pleura there is an inherent procedural risk that the biopsy could lead to a pneumothorax.Per the physician, the pneumothorax would have likely occurred via another modality.In this case, the size of the lesion biopsied was 13-15 mm and was touching the pleura.The lesion was located in the left upper lobe (lul).The procedure was completed and several hours later a standard postoperative chest x-ray did not reveal any relevant pathologic findings.The patient was discharged home without issues.Hours later, the patient experienced subcutaneous emphysema, crepitus, and shortness of breath and went to the emergency room.The patient was admitted and a chest tube was placed.No other treatment interventions were provided.The patient was admitted for a total of 7 days.The patient was discharged home in stable condition.There is no allegation that a malfunction of an ion system, instrument, or accessory occurred.
Additional Manufacturer Narrative
Based on the information provided, the root cause of the customer reported complication cannot be determined.There is no allegation that a malfunction of an ion system, instrument, or accessory occurred.A follow-up mdr will be submitted if additional information is received.Per an intuitive surgical, inc.(isi) senior failure analysis engineer, a system log review cannot be performed because the system logs are not available at the time of this report.No video/images were provided by the customer for review.This complaint is being reported due to the following conclusion: after completion of an ion endoluminal lung biopsy procedure, a patient developed a pneumothorax.A chest tube was placed to resolve the pneumothorax.The patient was hospitalized for 7 days and then discharged home in stable condition.The cause of the complication is unknown.There is no allegation that a malfunction of an ion system, instrument, or accessory occurred.Blank mdr fields: follow-up was attempted, but the missing patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.Field is not applicable because the product is not implantable.Field is blank because it is unknown if the initial reporter submitted a report to the fda.Fields are not applicable.Field is blank because insufficient product information was provided in order to obtain the date of manufacturer.

• Brand Name: ION
• Common Device Name: SYSTEM CART
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 14794459
• Report Number: 2955842-2022-12339
• Device Sequence Number: 17367266
• Product Code: EOQ
• UDI-Device Identifier: 00886874116241
• UDI-Public: (01)00886874116241
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K182188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 380707-33
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ION ENDOLUMINAL SYSTEM
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American